This workshop on cell and gene therapies aims to meet the needs of the developers of advanced therapies to discuss a range of topics that will help them make more informed decisions on regulatory strategies and evidence packages - as well as market access challenges - which are key topics for cell and gene therapy developers.
It will feature speakers from regulators, payers, patients, industry and academic organisations. Participants will benefit from the direct interaction with these stakeholders as a part of the main programme and during the networking events.
- Development challenges and solutions for cell and gene therapies
- Regulatory tools and pathways, incl. early interaction with decisions
- Emerging gene editing technologies and the ethical challenges
- Hospital exemption issues
- Post-licensing evidence with examples from country-level initiatives
- HTA and value assessment for curative therapies with high upfront fee
- Case study for a launch in Europe
Who should attend?
- R&D, regulatory and access professionals from organisations developing cell and gene therapies
- Regulators, payers and patients who are impacted by or participating the decisions or policies related to cell and gene therapies
Alexander Natz, JD • Secretary General
European Confederation of Pharmaceutical Entrepreneurs, Belgium
Maren von Fritschen, PharmD • DIA Chair Regional Advisory Council EMEA
Addon Pharma, Germany
Inka Heikkinen, MS, MSc • Associate Director, Global Regulatory Policy
Thomas Bols • Head of Government Affairs and Public Policy, EMEA & APAC
PTC Therapeutics, Inc., Switzerland